MDACC Study Summary 2006-0442

Study Summary
No. 2006-0442:.......Prostate......Paul Corn......Genitourinary Medical Oncology

Study Summary Title



Study Summary Number:	2006-0442

Study Title:	KHAD: An Open-Label Phase II Study of Ketoconazole, Hydrocortisone and Dutasteride in Asymptomatic Hormone Refractory Prostate Cancer

Physician

New Patient Referral



Name:	Paul Corn	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Genitourinary Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2830 Contact us about clinical trials

General Information



Disease Group:	Prostate	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Participants will return to clinic every 4 weeks.

Treatment Agents:	Dutasteride Hydrocortisone Ketoconazole	Home Care:	All study drug will be prescribed to the participant and taken by mouth at home.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if the combination of dutasteride, ketoconazole, and hydrocortisone will control castration-resistant prostate cancer. The safety of this drug combination will also be studied.

Study Objectives / Outcomes

Primary
• To evaluate the efficacy of high dose ketoconazole and hydrocortisone in combination with dutasteride (KHAD) in the treatment of hormone refractory prostate cancer (PSA response).

Secondary
• To evaluate the toxicity of the combination in hormone refractory prostate cancer.
• To determine the time to progression on KHAD.
• Correlate levels of androgens and metabolites with response.

Study Status Information



Study Activation / Registration Date:	10/26/2006

IRB Review and Approval Date:	07/05/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	57

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Histologically documented evidence of prostate cancer (needle biopsy or prostatectomy). In the absence of histologically documented evidence of prostate cancer (needle biopsy or prostatectomy), the diagnosis of prostate cancer must be based on an elevated serum PSA (> than 20ng/ml) and metastatic lesions on bone scan.

2) Progressive HRPC defined as a PSA increase over baseline of >25% or 5ng/ml or new lesions on bone/CT scan after conventional androgen deprivation and antiandrogen withdrawal. Evidence of metastatic disease based on positive CT or bone scan is not required for eligibility in HRPC patients.

3) PSA >/= 2 ng/ml and serum total testosterone </= 50 ng/ml.

4) No prior therapy with ketoconazole or corticosteroids for HRPC.

5) Prior chemotherapy is permitted if discontinued > 4 weeks prior to starting therapy.

6) Prior therapy with estrogens is permitted but must have been discontinued >/= 4 weeks prior to registration.

7) ECOG performance status 0-2.

8) Patients who are on LHRH agonists or antagonist must be continued on this medication.

9) Adequate renal function (serum creatinine </= 2x upper limit of normal), hepatic function (bilirubin </= 1.5 x upper limit of normal; AST </= 1.5 x upper limit of normal; ALT </= 1.5 x upper limit of normal), and bone marrow function (WBC >/= 1500, Hgb >/= 10, platelets >/= 75k).

10) No major surgery or radiation therapy within 4 weeks.

11) No strontium-89 or samarium-153 therapy within 4 weeks.

12) Signed informed consent.

13) ECG showing a normal QT interval (QT<450 msec).

14) No thromboembolism in past 6 months.

Exclusion Criteria:

1) Patients taking drugs that may further prolong QT intervals and present a known risk for Torsades de Pointes are excluded. Drugs in this class as indicated by the FDA are cisapride, clindamycin, moxifloxacin, gatifloxicin, sparfloxicin, and Sandostatin. Additional drugs are indicated on a web site from University of Arizona (www.qtdrugs.org)

2) The concomitant use of drugs known to be narrow therapeutic index CYP3A4 substrates is excluded (astemizole, cisapride, cyclosporin, ergotamine, fentanyl, quinidine, tacrolimus).

3) Drugs that are sensitive CYP3A4 substrates are excluded (buspirone, felodipine, lovastatin, midazolam, triazolam, simvastatin, sildenafil, vardenafil).

4) Patients who have alcohol or drug dependence currently or in the last 6 months are excluded from this study.

5) Any other events, other than those defined above, in the opinion of the investigator, may make the patient ineligible for this trial.

Links

Registration Number: NCT00673127
Study Information on Clinical Trials Registry (clinicaltrials.gov)